An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philip J. Rosenfeld, MD, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT00373659
First received: September 7, 2006
Last updated: June 12, 2012
Last verified: June 2012

September 7, 2006
June 12, 2012
August 2004
June 2007   (final data collection date for primary outcome measure)
  • Change in visual acuity vs baseline
  • Change in OCT central retinal thickness vs baseline
Same as current
Complete list of historical versions of study NCT00373659 on ClinicalTrials.gov Archive Site
  • Number of injections over 1 year
  • Number of consecutive monthly injections until fluid-free
  • Injection free interval
  • Correlations of injection frequency with baseline lesion characteristics and visual acuity
Same as current
Not Provided
Not Provided
 
An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study

This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.

In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neovascular Age-related Macular Degeneration
Drug: Ranibizumab (Lucentis)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 50 years or older
  • Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression
  • OCT central retinal thickness ≥ 300 microns
  • Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye

Exclusion Criteria:

  • More than 3 prior treatments with verteporfin photodynamic therapy
  • Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
  • Subfoveal fibrosis or atrophy in the study eye
  • History of vitrectomy surgery in the study eye
  • Aphakia or absence of the posterior capsule in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373659
IST-FVF3102
No
Philip J. Rosenfeld, MD, PhD, University of Miami
University of Miami
Not Provided
Principal Investigator: Philip J Rosenfeld, MD PhD University of Miami
University of Miami
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP